Quick Facts at a Glance
- Recall Date
- June 10, 2025
- Hazard Level
- HIGH
- Brand
- SEDECAL
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 3 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SEDECAL
- Product type
- Mobile X-ray system
- Model numbers
- SM-40HF-B-D-C, 40KW70CDEMO.005, UDI/DI 08436046001510, G38652, G37633, G36042, G37641, 608A +1 more
- Sold at
- Multiple Retailers
- Where affected
- CA, IL, NJ
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 10, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
About This Product
Sedecal SM-40HF-B-D-C and the 40KW70CDEMO.005 are mobile X-ray systems used in clinical imaging within hospitals and clinics.
Why This Is Dangerous
The devices are not water-resistant and must be cleaned only as described in the manual. Improper cleaning could damage the unit or lead to operational issues.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals must halt use of the affected units to prevent potential damage or malfunction affecting patient imaging services.
Practical Guidance
How to identify if yours is affected
- Check model numbers SM-40HF-B-D-C and 40KW70CDEMO.005.
- Confirm UDI/DI 08436046001510.
- Cross-check against distribution list CA, IL, NJ.
Where to find product info
Recall details available at the FDA enforcement page linked in the notice. Serial numbers and UDI/DI appear on the unit label and in the device documentation.
What timeline to expect
No remediation timeline provided. Recalls for medical imaging equipment vary by facility and manufacturer.
If the manufacturer is unresponsive
- Document outreach efforts to Sedecal SA and your healthcare provider.
- Escalate to the hospital’s risk management team if the manufacturer is unresponsive.
How to prevent similar issues
- Ensure cleaning procedures strictly follow the manual for any medical imaging device.
- Train staff on the specific cleaning requirements and water exposure limits.
Documentation advice
Keep a copy of the recall notice, serial numbers, model numbers and all correspondence with Sedecal SA and healthcare providers for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers SM-40HF-B-D-C and 40KW70CDEMO.005. Distribution US: CA, IL, NJ. Sold unknown. Price unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model SM-40HF-B-D-C; 40KW70CDEMO.005
- Distribution: CA, IL, NJ (US)
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
